PharmaDrug Inc announced that, in collaboration with the Terasaki Institute for Biomedical Innovation (TIBI), it has successfully completed the fabrication of a novel medical device capable of delivering sustained, low (sub-psychedelic) quantities of a tryptamine-based pharmaceutical to the front of the eye.
PharmaDrug said the intended purpose is to potentially lower intraocular pressure (IOP) in patients suffering from glaucoma.
Additionally, the company said a head-to-head drug elution study of its three undisclosed DMT-analogue candidates has now been completed while supportive cell-based biocompatibility has been examined for all three candidate molecules.
READ: PharmaDrug announces positive results from DMT-analogue program to treat glaucoma
Future in vivo efficacy testing in an accepted model of primary open-angle glaucoma (POAG) is currently being planned with the goal of providing all necessary support to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to conduct clinical studies, the company said.
"We are excited to announce that our recently fabricated proprietary medical device, designed to deliver controlled release of tryptamine-based pharmaceutical agents, has now progressed from the concept stage into a functioning prototype,” said Paul Van Slyke, chief science officer for PharmaDrug, in a statement.
“Drug release rates were successfully characterized for each of the candidates under evaluation and as such, the current studies provide the company with the critical data necessary to fine-tune fabrication efforts while also facilitating informed design for its future IND-enabling efficacy studies which will use a well-accepted animal model of glaucoma."
PharmaDrug said the aim of its DMT-analogue research program in ocular health is to develop suitable prototype medical devices capable of sustained ocular drug-delivery while also confirming efficacy, biocompatibility, and stability of its candidate molecules in models of elevated IOP.
New medical device
Meanwhile, the company said it has delivered on several additional key objectives -- namely fabrication of its drug-eluting medical device and in vitro biocompatibility test results. The research program scope currently underway includes full establishment and demonstration of candidate molecule loading capacity, release rate evaluations for conjugated materials as well as model organism testing to support an IND application with the FDA in the future.
The company has now completed fabrication and initial testing of its novel medical device designed to deliver therapeutic quantities of its DMT-analogues to the front of the eye.
Specifically, drug-loaded medical device prototypes were suspended in a biological solution meant to mimic the somewhat harsh environment of the eye. Samples, maintained at body temperature were removed at defined periods of time over 16 days and were quantified to determine the concentration and rate of drug elution for each of the company's three candidate molecules.
The company noted that the stability of one of the candidate molecules did not meet minimal necessary criteria and has now been eliminated from further consideration. The remaining two DMT-analogues displayed suitable two-week provisional stability and elution characteristics that support further evaluation and optimization.
One candidate molecule/medical device, in particular, displayed a consistent drug elution profile from days 2-16 (end of study) -- suggesting that drug delivery of greater than two weeks may be possible.
The biocompatibility of drug-loaded medical devices was examined by way of monitoring cell proliferation and live/dead staining on human ciliary muscle cells over time. Concentrations expected to be within the therapeutic range were found to not statistically impact cell viability for any of the drug-loaded medical devices.
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